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EC number: 217-968-7 | CAS number: 2022-85-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-05-17 to 2005-07-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Commission Directive 96/54/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to Annex XI section 1.1.2. of Regulation (EC) No 1907/2006 (REACH) testing of skin sensitisation in an in vivo LLNA is not necessary if there are data that is generated by studies not carried out according to GLP or the test methods reffered to in Article 13 (3) of the same regulation, if the data is sufficcient for the purpose of classification and labelling and/or risk assessment and if the key parameters foreseen to be investigated in the recommended methods are reliably covered, the exposure duration is similar to that of the recommended methods and if the study is adequate and reliable documented. The present GPMT was conducted according to OECD guideline 406, which is reliable without restrictions and adequate for classification and labelling purposes. It is well documented, measures the recommended key parameters and exposure duration is comparable to an in vivo LLNA. Thus, due to the provided reliable and adequate data the perfomance of an in vivo LLNA is not necessary.
Test material
- Reference substance name:
- Flucytosine
- EC Number:
- 217-968-7
- EC Name:
- Flucytosine
- Cas Number:
- 2022-85-7
- Molecular formula:
- C4H4FN3O
- IUPAC Name:
- flucytosine
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 300-450 g
- Housing: The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum, (Certified Guinea Pig Diet (Code 5026) supplied by BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): ad libitum, mains tap water
- Acclimation period: At least 5 days
- Indication of any skin lesions: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% (w/w)
- Day(s)/duration:
- single injection one week before the epicutaneous application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50% (w/w)
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50 and 25 % (w/w)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 in the main test and 5 control animals
- Details on study design:
- RANGE FINDING TESTS: Groups of guinea pigs were treated with various concentrations of test material, either intradermal or epicutaneously.
For intradermal induction 0.1 mL /injection site of a test solution with 5% (w/w) test substance was applied to one animal. Reading intervals were 24, 48, 72 h and 7 days after injection. The concentration caused only mild to moderate skin irritation, was well tolerated systemically, and was selected for the intradermal induction stage of the main test. For epicutaneous application two guinea pigs (intradermally injected with Freund's Complete Adjuvant ten days earlier) were treated with preparations of the test material (50%, 25%, 10% and 5% w/w in distilled water) under occlusive conditions for 48 h. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal initation was selected for the topical induction stage of the main test. Selection of the challenge concentration was performed by application of 4 concentrations of the test material (50, 25, 10 and 5% (w/w) in distilled water to the clipped flanks of two guinea pigs. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 7 days
- Test groups: test material in FCA
- Control group: FCA only
- Site: shoulder region
- Frequency of applications: single injection followed by a topical 48 h exposure after 7 days
- Concentrations: Intradremal injection with 0.1 mL (5% (w/w) of the test substance, after 7 days epicutaneous application of 50 % (w/w) of the test substance for 48 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period:
- Test groups: 50 and 25 % of the test material in distilled water
- Control group: 50 and 25 % of the test material in distilled water
- Site: shoulder region
- Concentrations: 50 and 25 % (w/w) test substance
- Evaluation (hr after challenge): 24 and 48 h
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- The results of the historical positive controls were depicted in table 1. 2-Mercaptobezothiazole produced a sensitisation 80 and 90 % of the male and female guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1. Summary of positive control Data for the Magnusson and Kligman Maximisation Study
Number of Animals and Sex |
Positive Control Material |
Concentration |
Incidence of Sensitisation |
|||
Test |
Control |
Induction |
Challenge |
|||
Intradermal |
Topical |
|||||
10 Male |
5 Male |
2-Mercaptobenzothiazole |
5% in arachis oil BP |
50% in acetone/PEG 400 (70:30) |
50 and25% in acetone/PEG 400 (70:30) |
80% (8/10) |
10 Male |
5 Male |
2-Mercaptobenzothiazole |
5% in arachis oil BP |
50% in acetone/PEG 400 |
50 and25% in acetone/PEG 400 (70:30) |
80% (8/10) |
10 Female |
5 Female |
2-Mercaptobenzothiazole |
5% in arachis oil BP |
50% in acetone/PEG 400 (70:30) |
50 and25% in acetone/PEG 400 (70:30) |
90% (9/10) |
Table 2: Intradermal Induction – Individual Skin Reactions
Group |
Animal Number |
Grade of Erythema at Observation Site |
|||
24 h |
48 h |
||||
Left site |
Right site |
Left site |
Right site |
||
Test |
1 |
1 |
1 |
0 |
0 |
2 |
2 |
2 |
1 |
1 |
|
3 |
1 |
1 |
0 |
1 |
|
4 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
0 |
0 |
|
7 |
1 |
1 |
1 |
0 |
|
8 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
|
Control |
11 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
|
13 |
0 |
0 |
0 |
0 |
|
14 |
0 |
0 |
0 |
0 |
|
15 |
0 |
0 |
0 |
0 |
Table 3: Topical Induction – Individual Skin Reaction
Group |
Animal Number |
Skin reactions (Hours After Removal of Dressing) |
|||||
1 h |
24 h |
||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
||
Test |
1 |
1 |
0 |
Bs |
1 |
0 |
- |
2 |
1 |
0 |
- |
1 |
0 |
- |
|
3 |
1 |
0 |
Bs |
0 |
0 |
- |
|
4 |
1 |
0 |
Bs |
1 |
0 |
- |
|
5 |
1 |
0 |
Bs |
1 |
0 |
- |
|
6 |
1 |
0 |
Bs |
0 |
0 |
- |
|
7 |
1 |
0 |
- |
0 |
0 |
- |
|
8 |
1 |
0 |
- |
0 |
0 |
- |
|
9 |
1 |
0 |
Bs |
1 |
0 |
- |
|
10 |
1 |
0 |
- |
0 |
0 |
- |
|
Control |
11 |
1 |
0 |
Bs |
0 |
0 |
- |
12 |
1 |
0 |
- |
0 |
0 |
- |
|
13 |
1 |
0 |
- |
0 |
0 |
- |
|
14 |
1 |
0 |
- |
0 |
0 |
- |
|
15 |
1 |
0 |
- |
0 |
0 |
- |
Bs = Bleeding from intradermal induction site
- = No other reactions noted
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted according to OECD guideline 406 (adopted 17 July 1992) 10 male guinea pigs experienced intradermal injections and epicutaneous applications of the test substance as induction followed by an epicutaneous challenge 14 days after the last induction. After challenge no signs of sensitisation were detected, thus the test item is considered to be no sensitizer under the conditions of the test. In accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) the substance does not need to be classified and labeled as a sensitizer.
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